Recruiting
Phase 1

ICG

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT04084067

Conditions

Neoplastic Disease

Solid Tumor

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green

Study Details

Brief summary:

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible.

Primary Objective

To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:

1. Osteosarcoma
2. Neuroblastoma
3. Metastatic pulmonary deposits - closed to accrual

Exploratory Objectives

1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

Separate assessments will be made for the following different histologic categories based on their actual enrollment; this includes but is not limited to analyzing multiple arms together:

1. Ewing Sarcoma
2. Rhabdomyosarcoma (RMS)
3. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
4. Renal tumors
5. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Conditions

Neoplastic Disease

Solid Tumor

Study ID

NCT04084067

Start date

Feb 7, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.

Exclusion Criteria:

  • Subjects with a history of iodide allergies.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Patients with benign pathology.
  • Patients with brain tumors.
  • Pregnant female.
  • Patients with unilateral Wilms Tumor.

Study Design

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Indocyanine green (ICG)

Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.

Interventions

Indocyanine Green

IV

Primary outcome measure

  • Sensitivity rates of the ICG guided neoplastic disease identification [ Time Frame: up to 24 hours post-surgery ]

Central Contacts and Locations

Central contacts

Lindsay Talbot, MD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Lindsay Talbot, MD

888-226-4343referralinfo@stjude.org

Principal Investigator:

Lindsay Talbot, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Ewing Sarcoma
  • Liver tumor
  • Lymphoma
  • Metastatic pulmonary deposits
  • Neoplastic Disease
  • Neuroblastoma
  • Non-Rhabdomyosarcoma Soft Tissue Sarcoma
  • Nodules of unknown etiology
  • Osteosarcoma
  • Solid Tumor
  • Rhabdomyosarcoma
  • Renal tumors
  • Rare tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-04-30.